Meridia

(Generic versions may still be available.)

DRUG DESCRIPTION

MERIDIA® (sibutramine hydrochloride monohydrate) is an orally administered agent for the treatment of obesity. Chemically, the active ingredient is a racemic mixture of the (+) and (-) enantiomers of cyclobutanemethanamine, 1-(4-chlorophenyl)-N,N-dimethyl-?-(2-methylpropyl)-, hydrochloride, monohydrate, and has an empirical formula of C17H29Cl2NO. Its molecular weight is 334.33.

The structural formula is shown below:

MERIDIA® (sibutramine hydrochloride monohydrate) Structural Formula Illustration

Sibutramine hydrochloride monohydrate is a white to cream crystalline powder with a solubility of 2.9 mg/mL in pH 5.2 water. Its octanol: water partition coefficient is 30.9 at pH 5.0.

Each MERIDIA capsule contains 5 mg, 10 mg, and 15 mg of sibutramine hydrochloride monohydrate. It also contains as inactive ingredients: lactose monohydrate, NF; microcrystalline cellulose, NF; colloidal silicon dioxide, NF; and magnesium stearate, NF in a hard-gelatin capsule [which contains titanium dioxide, USP; gelatin; FD&C Blue No. 2 (5- and 10-mg capsules only); D&C Yellow No. 10 (5- and 15-mg capsules only), and other inactive ingredients].

What are the possible side effects of sibutramine (Meridia)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sibutramine and call your doctor at once if you have a serious side effect such as:

  • flu symptoms;
  • fast or pounding heartbeats;
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, uneven heartbeats);
  • new or worsening shortness of breath;
  • seizure (convulsions)
  • ...

Read All Potential Side Effects and See Pictures of Meridia »

What are the precautions when taking sibutramine hydrochloride monohydrate (Meridia)?

Before taking sibutramine, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: eating disorders (e.g., anorexia nervosa, bulimia nervosa), uncontrolled or poorly controlled high blood pressure, heart or blood vessel disease (e.g., coronary artery disease, history of heart attack or angina, congestive heart failure, abnormal heart rhythms, poor circulation in the arms/legs), stroke or TIA (transient ischemic attack).

Before using this medication,...

Read All Potential Precautions of Meridia »


Meridia Consumer (continued)

SIDE EFFECTS: Dry mouth, increased appetite, nausea, strange taste in the mouth, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing, or joint/muscle pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding/irregular heartbeat, numbness/tingling of the hands or feet, mental/mood changes (e.g., excitement, restlessness, confusion, depression, rare thoughts of suicide).

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount or color of urine, easy or unusual bruising/bleeding, black stools, vomit that looks like coffee grounds, yellowing eyes or skin, unexplained fever, shaking, unusual sweating, swelling of the arms/legs.

Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, chest pain, weakness on one side of the body, vision changes, trouble breathing.

Sibutramine may rarely cause a very serious condition called serotonin syndrome. Taking sibutramine with "triptans" used to treat migraine headaches (e.g., sumatriptan, eletriptan) or certain antidepressants including SSRIs (e.g., citalopram, fluoxetine, paroxetine) and NSRIs (e.g., duloxetine, venlafaxine) increases the risk of this reaction. Before taking sibutramine, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: severe mental/mood changes (e.g., hallucinations, unusual restlessness), loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitchy muscles.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking sibutramine, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: eating disorders (e.g., anorexia nervosa, bulimia nervosa), uncontrolled or poorly controlled high blood pressure, heart or blood vessel disease (e.g., coronary artery disease, history of heart attack or angina, congestive heart failure, abnormal heart rhythms, poor circulation in the arms/legs), stroke or TIA (transient ischemic attack).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, glaucoma (narrow angle type), untreated underactive thyroid disease, liver disease, kidney disease, gallstones, seizure disorder, bleeding disorders, depression, drug abuse.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Children may be at a greater risk for mental/mood changes (including rare thoughts of suicide) while using this drug.

This medication is not recommended for use during pregnancy. Women of child-bearing age should use effective birth control while taking this medication. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Meridia Patient Information Including Side Effects

Brand Names: Meridia

Generic Name: sibutramine (Pronunciation: si BUE tra meen)

  • What is sibutramine (Meridia)?
  • What are the possible side effects of sibutramine (Meridia)?
  • What is the most important information I should know about sibutramine (Meridia)?
  • What should I discuss with my healthcare provider before taking sibutramine (Meridia)?
  • How should I take sibutramine (Meridia)?
  • What happens if I miss a dose (Meridia)?
  • What happens if I overdose (Meridia)?
  • What should I avoid while taking sibutramine (Meridia)?
  • What other drugs will affect sibutramine (Meridia)?
  • Where can I get more information?

What is sibutramine (Meridia)?

Sibutramine affects chemicals in the brain that affect weight maintenance.

Sibutramine is used together with diet and exercise to treat obesity that may be related to diabetes, high cholesterol, or high blood pressure.

Sibutramine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of sibutramine (Meridia)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sibutramine and call your doctor at once if you have a serious side effect such as:

  • flu symptoms;
  • fast or pounding heartbeats;
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, uneven heartbeats);
  • new or worsening shortness of breath;
  • seizure (convulsions)
  • easy bruising or bleeding (nosebleeds, bleeding gums, or any bleeding that will not stop);
  • blood in your urine or stool;
  • weakness, restless feeling, confusion, anxiety, agitation, fever, overactive reflexes, joint pain, sweating, vomiting, tremors; or
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out.

Less serious side effects may include:

  • dry mouth, upset stomach;
  • loss of appetite;
  • dizziness;
  • runny or stuffy nose, sore throat, cough;
  • headache, back pain;
  • trouble sleeping (insomnia),
  • constipation.
  • hunger;
  • mild skin rash; or
  • changes in your menstrual period.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about sibutramine (Meridia)?

Do not use sibutramine if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use sibutramine before the MAO inhibitor has cleared from your body.

You should not take sibutramine if you are allergic to ir, or if you have severe or uncontrolled high blood pressure, an eating disorder (anorexia or bulimia), or if you are taking stimulant diet pills.

Before taking sibutramine, tell your doctor if you have glaucoma, high blood pressure, heart disease, a history of heart attack or stroke, liver or kidney disease, depression, underactive thyroid, seizures, a bleeding disorder, a history of gallstones, or if you are older than 65 or younger than 16.

Tell your doctor about all prescription and over-the-counter medications you use, especially antidepressants, narcotic pain medicine, or migraine headache medicines.

Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks along with a low calorie diet.

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